Phase I Trial of Envafolimab for Healthy Male Subjects

Healthy Male Clinical Trial

Official title:

A Randomized, Double-blind, Single-dose, Parallel Controlled Phase I Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Envafolimab in Healthy Male Subjects Before and After the Manufacturing Process Change

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849311
• Other study ID #: KN035-CN-BE
• Status: Recruiting
• Phase: Phase 1
• Start date: May 29, 2023
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: 3D Medicines
• Contact: Qing He
• Phone: 010-83605200-856
• Email: heq[@]gobroadhealthcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 2024
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Be able to fully read, understand, and sign the informed consent form;

2. Male subjects aged 18-45 years

3. Clinical examinations in the screening period are normal or abnormal without clinical significance;

4. A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg;

5. Use effective contraceptive methods from the beginning of the informed consent to 5 months after the use of the drug, and have no plans to give birth or donate sperm.

Exclusion Criteria:

1. Systolic blood pressure =140 mmHg/ diastolic blood pressure =90 mmHg or systolic blood pressure < 90 mmHg/ diastolic blood pressure < 60 mmHg, pulse > 100 beats /min or < 50 beats /min at screening or baseline examination;

2. QT interval (QTcF) =450;

3. Estimated glomerular filtration rate eGFR < 90 ml/min/1.73m2;

4. Thyroid function beyond the normal range;

5. ALT > ULN Or AST > ULN;

6. Prior treatment with a PD-1/L1 inhibitor;

7. Have taken any prescription drug, over-the-counter drug, any vitamin product or herbal or health product within 14 days prior to study drug administration;

8. Had a history of upper respiratory tract infection or other acute infection within 14 days prior to study drug administration;

9. Positive hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody or syphilis.

Related Conditions & MeSH terms

• Healthy Male

Intervention

Drug:
• Envafolimab with new manufacturing process
Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.
• Envafolimab with old manufacturing process
Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.

Locations

Country	Name	City	State
China	Beijing Gaobo Boren Hosipital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
3D Medicines (Sichuan) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	Area under the plasma concentration-time curve	From pre-dose to day 85
Primary	Cmax	concentration	From pre-dose to day 85
Secondary	AUC0-infinity	Area under the plasma concentration-time curve	From pre-dose to day 85
Secondary	Tmax	Time to maximum concentration	From pre-dose to day 85
Secondary	CL	Clearance	From pre-dose to day 85
Secondary	?z	Apparent terminal elimination rate constant	From pre-dose to day 85
Secondary	t1/2	Half-life (	From pre-dose to day 85
Secondary	Vd	Volume of distribution	From pre-dose to day 85
Secondary	Safety and tolerance	Adverse events (AE)	From pre-dose to day 85
Secondary	Immunogenicity assessment	Anti-drug Antibody (ADA)	From pre-dose to day 85